510(k) · Cleared
ClearedDione PEEK Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZheJiang Decans Medical Devices Co., Ltd. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on May 27, 2026 as substantially equivalent to K103060 (Arthrex, Inc., 2011) and 1 other predicate after a 244-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- May 27, 2026
- Review
- 244 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K971358 (1997). 30 ancestors in all, the oldest K915424 (1993). No later device cites it as a predicate yet.
- Root · 7 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 6 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 5 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 4 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 3 generations backK032167 Bio-Intrafix Tibial Screw and SheathMitek Worldwide · 2003
- 2 generations backK093912 Arthrex Tibial GraftboltArthrex, Inc. · 2010
- 1 generation backK103060 Arthrex Tibial GraftboltArthrex, Inc. · 2011
- This deviceK253130 Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −6 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −5 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −4 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −3 | K032167 | Bio-Intrafix Tibial Screw and Sheath | Mitek Worldwide | 2003 | — |
| −2 | K093912 | Arthrex Tibial Graftbolt | Arthrex, Inc. | 2010 | — |
| −1 | K103060 | Arthrex Tibial Graftbolt | Arthrex, Inc. | 2011 | — |
| 0 (this device) | K253130 | Dione PEEK Screw System | ZheJiang Decans Medical Devices Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103060 | Arthrex Tibial GraftboltSummary page 5…CFR 888.3040 Review Panel: Orthopedic 4. Predicate Devices The identification of predicates within this submission is as follows: • Arthrex Tibial GraftBolt System (K103060) - Primary Predicate Device • Biosure PK Interference Screw (K083635) - Additional Predicate Device • Gemini Medical Cage S… | 2011 |
| * | K083635 | Smith & Nephew Biosure PK Interference ScrewSummary page 5…ication of predicates within this submission is as follows: • Arthrex Tibial GraftBolt System (K103060) - Primary Predicate Device • Biosure PK Interference Screw (K083635) - Additional Predicate Device • Gemini Medical Cage System (K242267) - Reference Device • Gemini Cervical Fusion Cage Syst… | 2009 |
| † | K242267 | Gemini Medical Cage System | 2024 |
| † | K242195 | Gemini Cervical Fusion Cage System | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 5 of the 30 ancestors have a recall of any class.
- 1 other device also cites its predicate K103060.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The Dione PEEK Screw System is indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253130: Dione PEEK Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253130
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026